Drugs

‘Intended Use’ Guidance Disappoints Stakeholders: Analysis

Attorney Patricia Kaufman says a new FDA final rule amending the “intended use” regulations for drugs and medical devices “may come as a disappointment to those who were hoping that FDA would provide more clarity in its regulations regarding permissible activities. However, it is not surprising that FDA is rejecting ‘meticulous specificity,’ given the complexity of the issues involved.”

Kaufman says firms must continue to diligently consider on a case-by-case basis the effect that their design, marketing, and distribution activities could have on their products’ intended use.

She writes that the final rule is essentially the same as a 9/2020 proposed rule except that it adds language to the proposed device regulation that clarifies its applicability to devices that are granted marketing authorization or are 510(k)-exempt, in addition to those that are approved and cleared. The final rule withdraws portions of the 2017 final rule that was stayed indefinitely in 2018 after the agency received significant complex, substantive criticisms from stakeholders. The new final rule is effective 9/1.

“The importance of the final rule lies in the fact that a product’s intended use forms the basis for FDA’s enforcement activity in connection with off-label promotion, that is, whether firms are marketing their products in a manner that encourages a use other than that for which FDA approved it,” Kaufman writes. “The industry was hoping to gain some greater certainty with the amendments as to what will and will not make them vulnerable to FDA finding a new intended use. FDA opted instead for broad flexibility in light of the various fact-specific patterns of each situation.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome